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Trial Title:
Oral Microbioma and Oral Malignant Disease
NCT ID:
NCT05766150
Condition:
Oral Cancer
Oral Squamous Cell Carcinoma
Premalignant Lesion
Conditions: Official terms:
Mouth Neoplasms
Squamous Cell Carcinoma of Head and Neck
Precancerous Conditions
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
This case-control study aims to investigate if oral microbioma is associated with
developing oral (pre)malignant disease.
Criteria for eligibility:
Study pop:
Persons visiting oral and maxillofacial surgery department in Maastricht UMC or Radboud
UMC who meet the inclusion criteria can be included.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Patients ≥18 years in case of oral malignancy or premalignant disease, ≥40 years in
case of no malignant disease
- Patients are (partially) dentate (≥20 teeth)
- Patients who have given written informed consent to participate in this study
Exclusion Criteria:
- Patients with a history of radiotherapy in head and neck region
- Patients with a history of chemotherapy, immunotherapy or immunomodulating drugs
- Patients with a previous malginancy in head and neck region
- Edentulous patients (with or without implants)
- Patients with removable (partial) dentures
Gender:
All
Minimum age:
18 Years
Maximum age:
100 Years
Locations:
Facility:
Name:
Deptartment of Oral and Maxillofacial Surgery, Maastricht UMC+
Address:
City:
Maastricht
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Department of Cranio- & Maxillofacial surgery, Radboud UMC
Address:
City:
Nijmegen
Country:
Netherlands
Status:
Recruiting
Start date:
December 1, 2021
Completion date:
December 2024
Lead sponsor:
Agency:
Academisch Ziekenhuis Maastricht
Agency class:
Other
Collaborator:
Agency:
Radboud University Medical Center
Agency class:
Other
Source:
Academisch Ziekenhuis Maastricht
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05766150
